ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ZIWIG
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- Area under the curve (AUC) of the Receiver Operating Curve (ROC)
研究概览
简要总结
RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva.
The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group).
The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS.
The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France.
The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient over 18 years of age,
- •Patient from one of the 2 study populations:
- •Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ;
- •Control group
- •Patient able to carry out a mouth rinse,
- •Patient affiliated to the healthcare system,
- •Patient has dated and signed the consent form,
排除标准
- •Recent (<1 month) or ongoing bacterial or viral infection,
- •Known active oral or digestive mycosis,
- •Evolving, symptomatic or obvious oral pathology,
- •Known pregnancy,
- •Patient participating in another clinical research study,
- •Patient deprived of liberty by administrative or judicial decision or under guardianship ;
- •Subject refusing to take a saliva sample;
- •For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study;
- •For control group: medical history of neurological disease (excluding migraine).
结局指标
主要结局
Area under the curve (AUC) of the Receiver Operating Curve (ROC)
时间窗: Through the end of study inclusions, an average of 2 years
Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.
次要结局
未报告次要终点